MAUDE Adverse Event Report: AESCULAP AG SILICONE RING WITH NEEDLE; DISPOSABLE INSTRUMENTS

Model Number	PL595SU
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a silicone ring with needle (part # pl595su) was used during a laparoscopic gastrectomy procedure performed on (b)(6) 2021.According to the complainant, the silicone rings of the device were torn.Reportedly, while removing the hook needle from the abdominal wall before the end of surgery, the silicone rubber broke and the hook needle fell into the abdominal cavity.The fragment was recovered from the patient's body using x-ray.The complaint device was not available to be returned to the manufacturer for evaluation as it was discarded.The surgery time possibly extended due to intra operative x-ray examination to search for the needle in the operative field.An additional medical intervention was necessary.Additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: SILICONE RING WITH NEEDLE
• Common Device Name: DISPOSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11516224
• Report Number: 9610612-2021-00186
• Device Sequence Number: 3280789
• Product Code: GDG
• UDI-Device Identifier: 04046963909338
• UDI-Public: 4046963909338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PL595SU
• Device Catalogue Number: PL595SU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention