MAUDE Adverse Event Report: OWENS & MINOR HALYARD SAMM053-03 CIRCUMCISION TRAY; NAV 501719 FORCEP, CURV 5" MOSQ, HALST

Model Number 1047429

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

The product involved in the report was not returned for evaluation.An avid complaint was received with complaint number (b)(4) for sharp forceps laceration.It was reported that a sharp edge on the forceps caused a small laceration on the infant during the procedure.The patient was undergoing a circumcision procedure, the physician noticed a small amount of blood.He noted one prong of the curved forceps was abnormally sharp and withdrew the defective instrument for one that was not defective.At the end of the procedure, the infant had a small laceration on the glans from the sharp instrument.No other treatment was noted.All information reasonably known as of 21sep2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avid medical complaint database as complaint number (b)(4) and the o&m halyard adverse event assessment process as record (b)(4).

Event Description

An avid complaint was received with complaint number (b)(4) for sharp forceps laceration.It was reported by the nurse that a sharp edge on the forceps caused a small laceration on the infant during the procedure.The patient was undergoing a circumcision procedure, the physician noticed a small amount of blood.He noted one prong of the curved forcep was abnormally sharp and withdrew the defective instrument for one that was not defective.At the end of the procedure, the infant had a small laceration on the glans from the sharp instrument.No other treatment was noted.

Manufacturer Narrative

The product involved in the report was not returned for evaluation.An avid complaint was received with complaint number (b)(4) for sharp forceps laceration.It was reported that a sharp edge on the forceps caused a small laceration on the infant during the procedure.The patient was undergoing a circumcision procedure, the physician noticed a small amount of blood.He noted one prong of the curved forceps was abnormally sharp and withdrew the defective instrument for one that was not defective.At the end of the procedure, the infant had a small laceration on the glans from the sharp instrument.No other treatment was noted.Information provided to supplier indicated that the device is not available for evaluation.However, a picture for the cvplp2000 was provided for evaluation.Medtronic's assessment was that the reported condition was not confirmed based on the picture.The most likely root cause could not be determined.Medtronic¿s assessment determined that manufacturing action is not required at this time.To ensure product oversight, this complaint report is incorporated into medtronic¿s complaint monitoring and tracking system.The manufacturing records for each device are thoroughly reviewed to ensure the product meets its quality specifications.Should new information become available the file will be re-opened and the investigation summary will be amended as appropriate.All information reasonably known as of 09nov2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by o&m halyard, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to o&m halyard, inc.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avid medical complaint database as complaint number (b)(4) and the o&m halyard adverse event assessment process as record ch-dt-2021-a1-41.This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or caused serious injury.H3 other text : device not returned.

Manufacturer Narrative

Sample was received and evaluated by the instrument manufacturer, fine surgical instruments.The supplier was unable to replicate the issue.The manufacturer has placed the forcep on 100% inspection prior to release.Correction: it was originally reported that medtronic was the supplier; however, the supplier is fine surgical ¿information provided to the supplier indicated that the device (part number 12-183 forcep , curv 5" mosq, halst from fine surgical instruments was available for evaluation.Fine surgical immediately quarantined all 12-183 forceps until they could all be physically inspected.Fine surgical also notified their manufacturer of this complaint that the forceps were too sharp.Going forward all instruments will be 100% inspected before any are released.¿ all information reasonably known as of 08dec2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avid medical complaint database as complaint number (b)(4) and the o&m halyard process as record (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or caused serious injury.

Manufacturer Narrative

We received notification from esg fda that the system would be down from 09dec2022 - 12dec2022 due to maintenance and there would be no 3rd acknowledgements sent out.We submitted an emdr follow-up on 08dec2022 before the maintenance was to be performed and received the 1st and 2nd acknowledgement but not the 3rd.At the request of the fda we were instructed to resubmit the emdr follow-up but we got a failed 3rd acknowledgement.We are therefore, resubmitting.Sample was received and evaluated by the instrument manufacturer, fine surgical instruments.The supplier was unable to replicate the issue.The manufacturer has placed the forcep on 100% inspection prior to release.Correction.It was originally reported that medtronic was the supplier; however, the supplier is fine surgical ¿information provided to the supplier indicated that the device (part number 12-183 forcep , curv 5" mosq, halst from fine surgical instruments was available for evaluation.Fine surgical immediately quarantined all 12-183 forceps until they could all be physically inspected.Fine surgical also notified their manufacturer of this complaint that the forceps were too sharp.Going forward all instruments will be 100% inspected before any are released." all information reasonably known as of 15dec2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avid medical complaint database as complaint number (b)(4) and the o&m halyard process as record ch-dt-2021-a1-41.This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or caused serious injury.

• Brand Name: SAMM053-03 CIRCUMCISION TRAY
• Type of Device: NAV 501719 FORCEP, CURV 5" MOSQ, HALST
• Manufacturer (Section D): OWENS & MINOR HALYARD; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): AVID MEDICAL; 9000 westmont drive; toano VA 23168
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 12510588
• MDR Text Key: 272645063
• Report Number: 1047429-2021-00006
• Device Sequence Number: 1
• Product Code: OKV
• UDI-Device Identifier: 10809160325049
• UDI-Public: 10809160325049
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1047429
• Device Catalogue Number: 501719
• Device Lot Number: 1438361
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 10/15/2021; 11/11/2022; 12/08/2022
• Supplement Dates FDA Received: 11/09/2021; 12/08/2022; 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other