MAUDE Adverse Event Report: AESCULAP AG PURSE STRING CLAMP 60MM JAW 280MM; STOMACH AND INTESTINAL FORCEPS

Model Number	EA323R
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwath will be submitted.
Event or Problem Description
It was reported to aesculap ag that a purse string clamp 60mm jaw 280mm (part # ea323r) was used during a procedure performed on an unknown date.According to the complainant, the intestinal tissue crushed during surgery.The surgeon complained that he had so much tension that the intestinal tissue was no longer clamped, but was crushed.Additional information was received on february 3, 2022 which revealed that "during esophageal surgery, the esophagus slipped out of the clamp." this resulted in a procedureal delay of approximately fifteen (15) minutes.The complaint device was returned to the manufacturer for evaluation.The patient harm is currently unknown.The malfunction is filed under aag reference (b)(4).
Event or Problem Description
Clarification: the patient harm was updated to significant surgery delay.
Additional Manufacturer Narrative
B5: surgical delay clarified.
Additional Manufacturer Narrative
Additional information/correction: according to review of the investigation, this event is considered no longer reportable for the following reason: case was evaluated within product safety case (psc) due to contraindication.The failure mode risk analysis has been adjusted to 2(5).Investigation: visual investigation: here we detected that the product is in our specifications.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.If the review shows any conspicuities, the report will be updated and actions will be initiated.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale: there are no hints of a pre-damage or similar, products are according to the specifications valid at the time of production.According to the instructions for use (ifu), this product is not intended for use at the esophagus.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 on the investigation results, a capa is not necessary.

• Brand Name: PURSE STRING CLAMP 60MM JAW 280MM
• Common Device Name: STOMACH AND INTESTINAL FORCEPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13443953
• Report Number: 9610612-2022-00030
• Device Sequence Number: 19909720
• Product Code: HTD
• UDI-Device Identifier: 04046963715984
• UDI-Public: 4046963715984
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EA323R
• Device Catalogue Number: EA323R
• Device Lot Number: 4512285829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 02/03/2022; 04/21/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 02/23/2022; 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown