MAUDE Adverse Event Report: AESCULAP AG SHUMACHER BIOPSY/RNGURSM-TIPSTR240MM; GENERAL SURGICAL INSTRUMENTS

Model Number	ER063R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with er063 - rshumacher biopsy rngursm-tipstr240mm.According to the complaint description, the removal of the tissue is very difficult.The instruments hook and the patients experience great pain and heavy bleeding afterwards.An additional medical intervention was necessary.Additional information was not provided nor available was not available.Additional patient information is not available.The adverse event malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00180 ((b)(4) er063r).
Additional Manufacturer Narrative
Investigation results: visual investigation: the products arrived in a clean status with no visible damage.One product hook during closing the jaws and one product cannot be closed.The investigation was carried out visually and microscopically.Here we found one product with a non-closing jaw and with a burr at the tip of the jaw.Additionally we detected burrs and a protruding area.All the products shows these or similar occurrences.Furthermore we discovered two products with burrs at the guiding rail.Batch history review: the device quality and manufacturing history records (dhr) will be checked for the leading device(s) lot number(s) from the quality coordinator of the production plant.The results of the review will be documented in pc notification.If the review shows any conspicuities, the report will be updated and actions will be initiated.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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.Based upon the investigations results a product safety case (psc 2019-055) was initiated.The production department will be informed about the investigation results and the products will be provided.If the review shows any conspicuities, the report will be updated and actions will be initiated.
Event or Problem Description
Associated medwatch-reports: 9610612-2021-00161(400503235 er063r), 9610612-2021-00180(400503837 er063r).

• Brand Name: SHUMACHER BIOPSY/RNGURSM-TIPSTR240MM
• Common Device Name: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11466205
• Report Number: 9610612-2021-00161
• Device Sequence Number: 19759301
• Product Code: HFB
• UDI-Device Identifier: 04038653154838
• UDI-Public: 4038653154838
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 10/01/2021

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: ER063R
• Device Catalogue Number: ER063R
• Device Lot Number: 4511733728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 10/01/2021
• 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: Other